Non-interventional-study With Tacrolimus Sandoz© Capsules for Prophylaxis of Renal Graft Rejection

Chronic Kidney Insufficiency Clinical Trial

Official title:

A Single-site, Prospective Non-interventional-study With Adport Sandoz© Capsules for Prophylaxis of Graft Rejection in Patients With Stable Kidney Function After Renal Allograft.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01353417
• Other study ID #: TAC SAN NIS 2011
• Status: Completed
• Phase: N/A
• First received: May 12, 2011
• Last updated: April 5, 2017
• Start date: April 2011
• Est. completion date: August 31, 2015

Study information

• Verified date: April 2017
• Source: Sandoz
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

This non-interventional study intends to collect epidemiological data in patients with stable kidney function after renal transplantation, who receive Tacrolimus Sandoz© according to the approved indication.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 102
• Est. completion date: August 31, 2015
• Est. primary completion date: August 31, 2015
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Age: = 18

• Post renal transplantation time: = 6 months

• Stable kidney function ( serum creatinine < 3.0mg/dl; variation < 0.5mg/dl at 2 appointments in minimum distance of 6 days)

• Stable Tacrolimus Sandoz© dose > 2 weeks before inclusion in this Non Interventional Study (NIS)

• Written and oral informed consent

Exclusion Criteria:

• Well-known poor compliance with immunosuppressives

• Acute rejection reaction within the past 3 months or antibody-therapy because of rejection within the past 6 months

Related Conditions & MeSH terms

• Chronic Kidney Insufficiency
• Renal Insufficiency
• Renal Insufficiency, Chronic

Intervention

Other:
• In this observational study no study specific intervention is planned
Patients with stable kidney function who already receive Tacrolimus Sandoz© capsules before being included in this non-interventional study, are being observed for 6 months by their attending physicians. Routine medical treatment is provided.

Locations

Country	Name	City	State
Austria	General Hospital	Vienna

Sponsors (1)

Lead Sponsor	Collaborator
Sandoz

Country where clinical trial is conducted

Austria, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Changes in Adport Sandoz© trough level		Observation time: 26 weeks
Secondary	Efficacy of Adport Sandoz© in prevention of renal graft rejection by observing serum creatinine levels		Observation time: 26 weeks
Secondary	Incidence of serious adverse drug reactions		Observation time: 26 weeks
Secondary	Incidence of adverse drug reactions		Observation time: 26 weeks
Secondary	Incidence of serious adverse events		Observation time: 26weeks